Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
- Registration Number
- NCT03132194
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
- Detailed Description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1125
Inclusion Criteria
- Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Exclusion Criteria
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Gel Placebo Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days. Aczone Aczone dapsone 7.5 Topical, twice daily on the face for 84 days. DPSG 7.5% DPSG 7.5% DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days.
- Primary Outcome Measures
Name Time Method Change in inflammatory lesion counts 12 weeks Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts 12 weeks Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
- Secondary Outcome Measures
Name Time Method Clinical response of success 12 weeks The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment